COVID-19 Guidance
Refer to the following for general information and guidance on COVID-19:
- Important Therapeutic Goods Administration (TGA) Medicines Shortage Advice regarding intravenous Tocilizumab (Actemra) in clinical trial settings.
- Clinical Trials Project Reference Group (CTPRG) national guidance: COVID-19 Guidance on clinical trials for institutions, HRECs, researchers and sponsors
- Combined industry guidance: Joint Position Statement from Research & Development Taskforce (RDTF) – Supporting Clinical Trials during the COVID-19 pandemic
- NHMRC COVID-19 impact statement
Victorian HREC Research Managers COVID-19 statement:
"In response to the unprecedented COVID-19 pandemic, Hospital Research Ethics & Governance Offices across Victoria are working to ensure that ethics and governance reviews of COVID-19 related clinical trials and health research projects are encouraged, supported and expedited to meet these challenging times.
We ask for patience, flexibility and creativity from all stakeholders as we work together to accelerate research during this rapidly evolving healthcare emergency.
The Hospital Research Managers Sub-Committee is supported by the Melbourne Academic Centre for Health, Monash Partners and Western Alliance."
Please contact Monash Partners Academic Health Science Centre on 03 8572 2637 for further information regarding Victorian HRECs.
Refer to the Victorian hospital Research Office for contact details.
PICF for future Coronavirus or related research
A PICF template is available for the collection of health information and samples for future Coronavirus or related research. Information in the PICF refers to Victorian legislation. If using this PICF under NMA it will be necessary for other jurisdictions to insert specific legislation (if applicable) for health information and samples.
Refer to the following table for details.
Streamline e-Bulletin
This communication is open to all stakeholders in research and clinical trials sectors. Email us to register for the Streamline eBulletin: multisite.ethics@safercare.vic.gov.au
Past Streamline e-Bulletins
- Streamline eBulletin, February 2024
- Streamline eBulletin, April 2024
- Streamline eBulletin, January 2024
- Streamline eBulletin, December 2023
- Streamline eBulletin, October 2023
- Streamline eBulletin, August 202
Events
National Clinical Trials Governance Framework
Learnings from 2023. 06 February 2024
Australian Teletrial Program-Victoria (ATP-VIC)
Teletrials - Ethics, site governance and startup - 21 July 2023
- Suzanne Hasthorpe - Overview of ATP and setting the scene
- Michelle Tamplin and Nicoline Wedemeyer – Sponsor perspective
- Nicole Humphreys – Teletrials - A Regional Experience
- Anne Woollett – Teletrials - The primary site perspective
- Angela Henjak - HREC expectations when reviewing teletrials & case studies
Past annual May conferences
Annual May conference presentations – 01 May 2019
Streamlining Clinical Trials and Research: 10 Years in Victoria
- Lucas Litewka and Nicole Bechaz – Clinical Trials in a Primary Care Setting – A perspective based on the University of the Sunshine Coast Clinical Trials Centre (USC CTC) experience
- Martin Delatycki – Translating Research – the Experience of a Clinical Researcher
- David Ball – CHISEL (TROG 09.02); A Randomised Phase III Trial of Stereotactic Ablative Radiotherapy v Standard Radiotherapy for Stage I Non-small Cell Lung Cancer
- Dr Ieva Ozolins and Dr Katherine Clark – Clinical Trials and Biologicals
- Sabe Sabesan – Teletrial Implementation: Interplay between Clinics and Policy
- Melissa Hagan – How Queensland Health Operationalised the Teletrials Vision
- Suzanne Hasthorpe – National Mutual Acceptance and Teletrials Policy Development
Annual May conference presentations - 2 May 2018
Research Landscape - Advances and Changes
- Chantal Gebbie and David Speakman – Clinical Trial Access for Regional, Rural and Rare Cancer Patients using Telehealth - The Australasian Tele-trial Model
- Kym Short – eConsent – Where Are We Now?
- Mary Hayek – Neuroscience: What’s the Difference?
- Simon Barrett – The Paperless Committee
- Suzanne Hasthorpe – Early Phase Clinical Trials: A Toolkit for Expert Scientific Review
National mutual acceptance symposium
- James Cokayne Presentation
- Suzanne Hasthorpe Presentation
- Melissa Hagan Presentation
- Catherine Bourgeois Presentation
- Rebecca Nuhiu Presentation
- Kym Short Presentation
- Jaspreet Sidhu Presentation
Contact us
Contact the Coordinating Office for Clinical Trial Research:
- Email: multisite.ethics@safercare.vic.gov.au
- Phone: 0408 274 054 - General enquiries and ERM application advice
- Phone: 0408 410 938 - Enquiries and ERM for Research Office administrators
9am – 5pm AET, Monday – Friday
Forms
Ethics Checklist
Pro-forma checklist to assist with preparing an ethics application
(MS Word Document - 164.0 KB)
Jul-2024
Research Governance Checklist
To assist with preparing a research governance / Site Specific Assessment (SSA) application
(MS Word Document - 772.1 KB)
Mar-2024
Victorian Specific Module WORD version
For each research project that has a site in Victoria, the Victorian Specific Module (VSM) must be completed and submitted to the reviewing Human Research Ethics Committee (HREC) as part of the ethics application.
(MS Word Document - 69.2 KB)
Oct-2021
Evaluation of a site as a Satellite Site checklist
(MS Word Document - 160.3 KB)
Apr-2024
Primary Site Workflow checklist
(MS Word Document - 158.6 KB)
Apr-2024
Evaluation of a trial as a teletrial checklist.docx
(MS Word Document - 157.3 KB)
Apr-2024
Teletrial Registration Form
(MS Word Document - 142.8 KB)
Apr-2024
Guidelines
Applicant user guide to ERM
(PDF File - 13.6 MB)
Mar-2024
Coronavirus related PICF - Jurisdiction specific legislation table
If using the Participant Information Consent Form for non-interventional coronavirus research, it will be necessary for other jurisdictions to insert specific legislation if applicable.
(MS Word Document - 102.9 KB)
Mar-2024
Create a Human Research Ethics Application (HREA) in ERM
(PDF File - 352.7 KB)
Mar-2024
Creating SSAs for sites - by HREA owner
(PDF File - 264.0 KB)
Mar-2024
Creating SSAs for sites - SSA owner
(PDF File - 400.6 KB)
Mar-2024
Electronic Signatures and Clinical Trial Research Agreement execution in Australia
This paper provides guiding principles to optimise digital technology for executing CTRAs using eSignatures.
(PDF File - 236.3 KB)
20-Jul-2021
Guidance on Scientific Expert Review Toolkit
This document provides background information and guidance for a scientific expert reviewer to conduct scientific review, at the request of an ethics committee in Victoria, regarding early phase clinical trials.
(PDF File - 2.5 MB)
Mar-2024
HRECs, RGOs and Organisations
This document provides details and contact information for organisations taking part in the National Mutual Acceptance (NMA) initiative.
(PDF File - 587.6 KB)
Mar-2024
How to upload documents in ERM
(PDF File - 415.5 KB)
Mar-2024
Jurisdictional Legislative Requirements
This document aims to provide an overview of the various legislative and administrative frameworks that currently exist in Commonwealth, States and Territories and apply to the approval of human research under Mutual Acceptance of Ethics and Scientific Review. This document is not a substitute for legal advice.
(PDF File - 334.6 KB)
Dec-2023
Monitoring and Reporting Matrix
This matrix is designed to assist investigators, HREC Coordinators and Research Governance Officers. It provides information on reporting requirements for multi-centre human research projects taking place in Australia.
(MS Excel Document - 437.9 KB)
Mar-2024
National Mutual Acceptance (NMA) Ethics and Governance Matrix
Arrangements for ethics and research governance/Site Specific Assessment (SSA) applications across the NMA jurisdictions are described in this NMA Ethics and Governance Matrix table.
(PDF File - 187.8 KB)
Mar-2024
NMA Brochure
(PDF File - 247.5 KB)
Aug-2021
NMA Fact Sheet
(PDF File - 234.3 KB)
Mar-2024
NMA Standard Principles for Operation
(PDF File - 613.0 KB)
Mar-2024
NMA Data Linkage Guide
The National Mutual Acceptance (NMA) scheme has been revised to better support researchers undertaking multi-jurisdiction studies involving linkage of data.
(MS Word Document - 156.1 KB)
Mar-2024
NMA ethics application: Projects with a Western Australia site
Additional supporting documents that address state legislation e.g. Western Australian Specific Module (WASM) and Victorian Specific Module (VSM) may be required for some research projects.
(MS Word Document - 140.2 KB)
Mar-2024
Participant Information Consent Form and European Union General Data Protection Regulation
Dealing with requested amendments to the Participant Information Consent Form (PICF) following implementation of the European Union’s General Data Protection Regulation (GDPR).
(MS Word Document - 118.8 KB)
Mar-2024
Post approval and Post authorisation subforms in ERM
(PDF File - 254.6 KB)
Mar-2024
Roles and Responsibilities in a Research Project
(MS Word Document - 140.6 KB)
Mar-2024
Research governance and Site specific assessment - Process and practice (Appendices)
(MS Word Document - 580.1 KB)
Mar-2024
Research governance and Site specific assessment - Process and practice
The purpose of this document is to provide guidance to assist all sectors involved in clinical trials to understand the processes used to meet the regulatory requirements for clinical trial research
in Australia.
(PDF File - 1.1 MB)
Mar-2024
Signature requests and submission in ERM
(PDF File - 340.5 KB)
Mar-2024
Supporting Clinical Trials During the COVID-19 Pandemic
(PDF File - 269.1 KB)
Mar-2020
Victorian Hospital Research Office – Contact details
(MS Word Document - 149.6 KB)
Mar-2024
Victorian Specific Module Guidelines
These guidelines provide useful information and specific instructions for completing Sections 1, 2 and 3 of the Victorian Specific Module.
(PDF File - 351.8 KB)
Oct-2021
Victorian Specific Module (VSM) in ERM
For each research project that utilises the Human Research Ethics Application (HREA) form and has a site in Victoria, the Victorian Specific Module (VSM) must be completed and submitted to the reviewing Human Research Ethics Committee (HREC) as part of the ethics application.
(PDF File - 424.7 KB)
Mar-2023
Statutory Guidelines on Research
(PDF File - 217.3 KB)
Feb-2002
Use of Ionising Radiation-flow diagram
(PDF File - 148.1 KB)
Mar-2024
Laws relating to the provision of consent for persons that do not have decision-making capacity to participate in research.pdf
(PDF File - 203.3 KB)
Mar-2024
ATP Teletrial Support Program-ATP-VIC Supplementary Information_(January 2024)
(PDF File - 383.7 KB)
Apr-2024
REDCap, TSP process summary and PICFs_April 2024
(PDF File - 269.7 KB)
Apr-2024
Multisite Clinical Trials v Teletrials Matrix
(PDF File - 231.8 KB)
Apr-2024
Teletrial Support Program Guidelines
(PDF File - 273.3 KB)
Nov-2023
Templates
Clinical Trial Research Agreement
For an Investigator Initiated Study
(MS Word Document - 53.2 KB)
20-Jul-2021
Clinical Trial Research Agreement (CTRA) Teletrial subcontract
(MS Word Document - 52.5 KB)
Oct-2020
HREC Radiation Notification Letter
Template letter to use if Ionising radiation exposure in a research project is not considered to be additional to normal clinical management/care at the site and the reviewing HREC is in Victoria
(MS Word Document - 21.0 KB)
Nov-2019
Participant partner pregnancy PICF
In the event that a participant in an approved interventional clinical trial (or the participant’s partner) becomes pregnant during the course of the research, this Participant Information Sheet/Consent Form should be provided to the pregnant participant/partner.
(MS Word Document - 62.0 KB)
21-Jul-2021
Patient Information and Consent Form for Future Unspecified Non-Interventional Coronavirus or Related Research
(MS Word Document - 49.8 KB)
Jun-2020
PICF health and social science for self
(MS Word Document - 174.1 KB)
Aug-2019
PICF health and social science for parent and guardian
A Participant Information sheet should be aimed at parents/guardians when the potential participant is a child. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 4.2) for more information. Consideration should also be given to explaining the procedure to the child themselves in a manner appropriate to their maturity level.
(MS Word Document - 175.6 KB)
Aug-2019
PICF health and social science for person responsible/medical treatment decision maker
A Participant Information sheet should be aimed at persons responsible/medical treatment decision makers when the potential participant does not have decision making capacity or not competent to provide consent for themselves. Refer to The National Statement on Ethical Conduct in Human Research (Chapters 4.4 & 4.5) for more information. This Participant Information Sheet/Consent Form should not be used for parents/guardians of minors; an alternative template is available for parents/guardians.
(MS Word Document - 175.0 KB)
Aug-2019
PICF genetic for parent and guardian
Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device.
Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research.
(MS Word Document - 229.1 KB)
Sep-2023
PICF genetic for person responsible/medical treatment decision maker
Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device.
Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research.
(MS Word Document - 228.4 KB)
Sep-2023
PICF genetic for self
Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device.
Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research.
(MS Word Document - 221.8 KB)
Sep-2023
PICF interventional for parent and guardian
An Interventional Study is defined as administration of a drug, device or procedure that is not part of routine care, including all phases of a clinical trial.
(MS Word Document - 228.4 KB)
Sep-2023
PICF interventional for person responsible/medical treatment decision maker
A Participant Information sheet should be aimed at persons responsible when the potential participant does not have decision making capacity or not competent to provide consent for themselves. Refer to The National Statement on Ethical Conduct in Human Research (Chapters 4.4 & 4.5) for more information. This Participant Information Sheet/Consent Form should not be used for parents/guardians of minors; an alternative template is available for parents/guardians.
(MS Word Document - 233.7 KB)
Sep-2023
PICF interventional for self
Adult providing own content. An Interventional Study is defined as administration of a drug, device or procedure that is not part of routine care, including all phases of a clinical trial.
(MS Word Document - 222.3 KB)
Sep-2023
PICF non-interventional for parent and guardian
A Participant Information sheet should be aimed at parents/guardians when the potential participant is a child. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 4.2) for more information. Consideration should also be given to explaining the procedure to the child themselves in a manner appropriate to their maturity level.
(MS Word Document - 194.8 KB)
Jun-2020
PICF non-interventional for person responsible/medical treatment decision maker
A Participant Information sheet should be aimed at persons responsible/medical treatment decision makers when the potential participant does not have decision making capacity or not competent to provide consent for themselves.
(MS Word Document - 193.0 KB)
Jun-2020
PICF non-interventional for self
Adult providing own consent. A Non-Interventional research project involves clinical research where no interventional treatment is given to participants other than their routine care. It does not involve the administration of an investigational product, treatment or procedure. Examples include observational research and monitoring of participants.
(MS Word Document - 189.5 KB)
Jun-2020
Contact List Template
(MS Excel Document - 11.6 KB)
Jun-2022
Stand Alone Teletrial PICF
The Stand Alone Teletrial PICF is used for an approved trial when a teletrial will be added to the existing trial, instead of amending a Master PICF. This is used for the added Satellite Site(s).
(MS Word Document - 48.0 KB)
Feb-2023
Stand Alone Teletrial PICF for Person Responsible\Medical treatment decision maker
(MS Word Document - 45.3 KB)
Sep-2023